Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

TEVA'S AZILECT APPROVED AS PARKINSON'S THERAPY

Israel-based Teva Pharmaceutical has received approval from the U.S. FDA for
once-daily Azilect (rasagiline tablets) as a treatment for Parkinson's disease.
Azilect will become available in the U.S. within 8 to 10 weeks. It was approved
in Europe and in Israel in 2005.

The drug is approved both as initial monotherapy in early Parkinson's disease
patients and as adjunct therapy to levodopa in moderate-to-advanced stages of
the disease.

"Azilect fills an important unmet need, offering a new treatment which
uniquely combines efficacy, convenient once-daily dosing and good tolerability,"
said Israel Makov, president and CEO of Teva. "The upcoming launch of Azilect
represents a key milestone in our commitment to develop and bring to market
novel therapies for neurological diseases."